TARGET M0035474080Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540676467), received between Aug 1, 2017 and May 16, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PROCEDURE, ANEURYSM RECANALIZATION WAS OBSERVED AS THE RETREATMENT WAS PERFORMED WITH COILINGS. BASED ON THE SITE, THE ADVERSE EVENT ANEURYSM REOCCURRENCE WAS POSSIBLY RELATED TO THE SUBJECT DEVICE. THE OUTCOME OF THIS ADVERSE EVENT IS ONGOING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm

  MAUDE report 22038949 ↗
• MalfunctionFeb 8, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING THE PROCEDURE THE OPERATOR DELIVERED THE SUBJECT COIL TO THE ANEURYSM. HOWEVER, THE SUBJECT COIL FLUORO-SAVER MARKER WAS NOT ALIGNED WITH THE MICROCATHETER DISTAL MARK. THE SUBJECT COIL WAS DETACHED BY THE OPERATOR WITH MISALIGNED MARKS. ADDITIONALLY, THE ANEURYSM COULDN'T BE FILLED COMPLETELY. THERE WAS 5 MINUTES SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18670870 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING THE PROCEDURE. WHEN THE COIL (SUBJECT DEVICE) WAS DELIVERED TO THE LESION, THE DISTAL TIP WAS OBSERVED, TO BE THIN. THE COIL (SUBJECT DEVICE) WAS RETRIEVED AND THE DISTAL TIP WAS FOUND TO BE STRETCHED AND FRACTURED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE . AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18260815 ↗
• MalfunctionMay 31, 2022Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL AND COIL DELIVERY WIRE WAS FOUND BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548667 ↗
• MalfunctionAug 19, 2019Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL PREMATURELY DETACHED/SEPARATED INSIDE THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8906612 ↗
• MalfunctionOct 2, 2018Unintended Movement; Unintended Movement

  A (B)(6) FEMALE (HYPERTENSION, PREVIOUS SMOKER) UNDERWENT STENT ASSISTED COIL EMBOLIZATION OF ANEURYSM IN RIGHT MIDDLE CEREBRAL ARTERY (MCA) (B)(6) 2017. WHEN THE PATIENT WAS SEEN FOR FOLLOW-UP APPROXIMATELY ONE YEAR LATER (B)(6) 2018, IT WAS REPORTED THE COIL MIGRATED THROUGH THE STENT STRUTS AND WAS PROTRUDING SLIGHTLY INTO THE ARTERY, AS OBSERVED ON DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT; THE EVENT WAS NOTED TO RESOLVE WITHOUT SEQUELAE THE SAME DAY ((B)(6) 2018). ADDITIONAL INFORMATION FROM THE PHYSICIAN INDICATED THE STENT WAS USED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7928888 ↗
• InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT. POST-PROCEDURE THE PATIENT WAS NEUROLOGICALLY ASSESSED AS HAVING A MRS OF 0 (MODIFIED RANKING SCALE). 16 DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED HEADACHE THAT LASTED 9 DAYS. MEDICATIONS PROCHLORPERAZINE 10 MG IV AND DIPHENHYDRAMINE 12.5 MG WERE ADMINISTERED ON THE 19 DAYS POST-PROCEDURE AS OUT-PATIENT IN EMERGENCY DEPARTMENT (ED) IN ORDER TO TREAT THE HEADACHE. PRESCRIPTIONS FOR COMPAZINE 10 MG PO AND BENADRYL 25 MG PO WERE GIVEN TO THE PATIENT WHEN DISCHARGED FROM ED. THE HEADACHE WAS RESOLVED WITHOUT ANY RESIDUAL EFFECTS. IT WAS ALSO REPORTED THAT 16 DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED PHOTOPHOBIA AND INTERMITTENT BLURRED VISION THAT LASTED 9 DAYS AND WERE RESOLVED WITHOUT RESIDUAL EFFECTS. ACCORDING TO THE PHYSICIAN, THE HEADACHE, THE PHOTOPHOBIA AND INTERMITTENT BLURRED VISION WERE PROBABLY RELATED TO THE PROCEDURE AND TO THE STENT. IT WAS UNKNOWN IF THE HEADACHE THE PHOTOPHOBIA AND INTERMITTENT BLURRED VISION WERE RELATED TO THE IMPLANTED COILS. THE PATIENT WAS ASSESSED HAVING A MRS OF 0 AT 2-MONTH POST-INDEX PROCE

  Patient problems: Headache; Visual Disturbances

  MAUDE report 6853579 ↗
• MalfunctionAug 1, 2017Break; Break

  DURING PREPARATION, IT WAS REPORTED THAT THE DELIVERY WIRE OF THE COIL WAS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER CHANGING TO ANOTHER COIL. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6758988 ↗